Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Pharmacovigilance (inc PSURs/RMPs)

Pharmacovigilance (PV) is a multifaceted and multifunctional process which occurs throughout the product life-cycle. That is why BioVentures Consulting Limited is an ideal choice when it comes to our client’s needs for consultants who can interact with the PV group, and for applying regulatory expertise to PV documentation and their submission requirements. We can review the safety specification (to ensure that monitoring is adequate to identify previously unrecognised, or changes in signal patterns, of adverse events). BioVentures Consulting Limited has experience in helping to construct the pharmacovigilance plan and provide feedback to clients on its effectiveness in assessing the risk and benefits of medicines and actions to improve safe use.

We have helped in the compilation of our client’s Periodic Safety Update Reports (PSURs) and are able to compile or review documentation which brings together all available safety data in a pre-defined ICH format, as well as a critical analysis of the text, data interpretation, and the overall safety evaluation. In this regard we can assist MAH who are obliged to provide a PSUR to regulatory agencies for all approved medicines.

The PSUR and RMP are the central pillars in product life-cycle management support

BioVentures Consulting Limited can also work with clients on their legislative requirement to provide a set of pharmacovigilance activities which proactively identify, characterise and prevent or minimise risks relating to medicinal products in the form of Risk Management Plans (RMPs). This will include the risk communication strategy, risk minimisation interventions and the assessment of their effectiveness. The PSUR and RMP are the central pillars in product life-cycle management support and are used in the compilation of key regulatory documents such as the clinical overview, which need increasingly robust arguments on the benefit/risk profile.

BioVentures Consulting Limited can advise on the legislative framework (which is in a period of transition during a changing pharmacovigilance system) and ensure current compliance with Directive 2001/83/EC, as amended (Directive 2010/84/EU) and Regulation (EC) 726/2004 (Regulation (EC) 1285/2010), and the Rules Governing Medicinal Products in the EU: Volume IXa Pharmacovigilance.

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